(189 days)
An IV additive dispensing pin for aspiration from single-dose containers with a 20 mm vial closure diameter and a 22mm vial body diameter (6R/8R).
The Mini Spike Plus 6/8 R is an IV additive dispensing pin for aspiration from single-dose containers with the size 6R* or 8R*. It is intended for withdrawal and injection from/in vials. The Mini Spike Plus 6/8 R transfer device is used for the preparation of medications contained in vials with a 20 mm vial closure diameter and a 22mm vial body diameter. The device is for single use and to only be used with single use drug dose vials. The device is configured with a snap cap covering a luer lock female access, a grip plate which features an integrated air filter (0.45 um) and a standard plastic piercing spike. The device provides two separate internal channels: One for injection and withdrawal of fluids, One for the pressure equalization between the vial and the environment. When the device's spike is pierced into a rubber stopper of a drug vial, these channels enable a fluid transfer between a syringe (that is connected with the device's luer connector on the top) and the vial. The vial adapter enables a permanent connection between the Mini Spike Plus 6/8 R and the vial. During the pressure equalization process there is an air exchange with the environment. In order to prevent any contamination of drugs being stored in the vials the air passes a 0.45um bacteria retentive air filter.
The provided text describes a 510(k) premarket notification for a medical device called "Mini Spike Plus 6/8R." This document is for a medical device that does not utilize AI/machine learning. Therefore, the requested information pertaining to AI/ML device performance, such as acceptance criteria for AI models, sample sizes for test sets in AI studies, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, training set details, and ground truth establishment methods, is not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (Mini-Spike Plus) based on traditional medical device performance testing and biocompatibility.
Here's the information that is available from the provided text, related to the device's acceptance criteria and studies:
Acceptance Criteria and Device Performance (based on traditional medical device testing):
The document states that the Mini Spike Plus 6/8R device "has met all established acceptance criteria for performance testing and design verification testing." While specific numerical acceptance criteria values are not explicitly presented in a table alongside performance results, the document lists the tests performed, implying that the device passed these tests according to predefined criteria.
Based on the provided text, a table can be constructed to show the types of tests performed, which inherently represent the areas where acceptance criteria were applied. No numerical performance data is given to populate a "Reported Device Performance" column with specific results, only that the device "met all established acceptance criteria."
| Acceptance Criteria Category | Test Performed (Implied Acceptance Criteria) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Functional Performance | ISO 22413:2010: |
- Particle Contamination
- Fragmentation
- Air Tightness
- Free Flow
- Penetration Force
- Tensile Load
- Visual Inspection
- Chemical Analysis
ISO 80369-7:2016: - Luer Connector Leakage, Stress Cracking & Resistance Testing
- Dimensional Accuracy
Internal device performance test methods: - Fluid burst pressure of air filter membrane
- Dynamic tensile load between Mini Spike and Vial Adapter | "met all established acceptance criteria for performance testing and design verification testing." |
| Sterile Barrier System | ISO 11607-1: 2006/Amd1:2014, ASTM F 1980-16, ASTM F1886/F1886M-16, ASTM D4169-16, ASTM D4332-14, ASTM F88/F88M-15, ASTM F1929-15, ASTM F2096-11, ASTM F2252/F2252M-13, DIN 58953-6:2016, ISO 11607-2: 2006/Amd:2014: - Sterile Barrier System Validation | "met all established acceptance criteria for performance testing and design verification testing." |
| Microbiological/Contamination| USP , USP : - Bacterial Endotoxin (LAL Gel Clot Test)
USP : - Particulate Contamination | "met all established acceptance criteria for performance testing and design verification testing." |
| Biocompatibility | ISO 10993-1:2009 (evaluated according to this standard), performed tests: - Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010)
- Intracutaneous Reactivity / Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2006)
- Hemolysis (ISO 10993-4:2002/Amd1, ASTM F756 (2013))
- Material Mediated Pyrogenicity (ISO 10993-11:2006, USP 38 ) | "met all established acceptance criteria for performance testing and design verification testing." |
Information Not Applicable or Not Provided for AI/ML Devices:
- Sample sizes used for the test set and the data provenance: Not applicable. This is a traditional device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Study Proving Device Meets Acceptance Criteria:
The document states: "Functional performance bench testing was conducted to demonstrate that the Mini Spike Plus 6/8R device performs as intended. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device."
- Type of Study: Bench testing (in vitro mechanical and material testing).
- Reason for no clinical testing: The device's substantial equivalence was demonstrated through bench testing and biocompatibility testing, compared to a legally marketed predicate device with similar intended use and technological characteristics. The differences (primary "new component" being the Vial Adapter and a change in sterilization method) were addressed through specific performance testing to confirm they don't "raise new questions on safety and effectiveness."
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.